NCT01509248Unknown不适用
Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 110
研究概览
简要总结
- Population pharmacokinetics : The purpose of this study is
- to investigate the population pharmacokinetics of theophylline in premature Korean infants and to assess the influence of demographic and clinical covariates.
- Metabolomics : The purpose of this study are
- to predict serum theophylline levels and to assess CYP1A2 activities in premature infants by analyzing urinary metabolites of theophylline
- to examine which factors affect clearance of theophylline and CYP1A2 activity in premature infants
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn preterm infants (GA < 37 weeks)
- •Dx : Apnea of prematurity
- •Tx : Aminophylline / Theophylline
- •Informed consent of parents
排除标准
- •Major congenital anomaly
- •Expired within 72 hours
- •Proven secondary apnea
研究者
Han-Suk Kim
Associate Professor & Director of Neonatal Intensive Care Unit
Seoul National University Hospital
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